Recon: Spectrum cuts 75% of staff following FDA rejection; WHO to rename monkeypox as ‘mpox’

ReconRecon | 28 November 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA Accepts BLA for Roche & Sarepta’s DMD Gene Therapy (Biospace) (Pharma Letter) (Endpoints)
  • FDA won't hold adcomm for BioMarin's hemophilia gene therapy after all (Endpoints)
  • FDA pushes back Gamida Cell’s PDUFA date by three months (Endpoints)
  • FDA preps for DMD drug generics as Sarepta has yet to finish its confirmatory trial (Endpoints)
  • Industry groups, CVS pick apart FDA's proposed pathway for generics to carve out OTC indications (Endpoints)
  • Could US FDA Move Gene Therapy Regulation To Device Center In Years To Come? (Pink Sheet)
  • Suspended California cell therapy manufacturing site hit with FDA warning letter over major quality concerns (Endpoints)
  • Standardization Of Patient-Focused Core Clinical Outcomes Could Enable Labeling Comparisons (Pink Sheet)
  • US Bill Seeks To Eliminate Biosimilar Interchangeability Trial Burden (Pink Sheet)
  • ‘Skinny labels’ on biosimilar medicines saved Medicare $1.5 billion over a recent five-year period (STAT)
  • Former Merck CEO: Democracy and the drug industry are both in danger (STAT)
  • (Washington Post)
  • Researchers test mRNA technology for universal flu vaccine (Reuters)
  • Addiction Treatment Record-Sharing Overhauled in HHS Proposal (Bloomberg)
In Focus: International
  • EU Finalizes Option To Omit Expiry Date On Inner Labeling Of Investigational Drugs (Pink Sheet)
  • EMA Launches First RWE Studies Under Big Data Project (Pink Sheet)
  • Pfizer’s CEO rapped by regulator for making ‘misleading’ statements about children’s vaccines (The Telegraph) (Fierce)
  • Roche Wants EU Pharma Legislative Revision To ‘Dare Something New’ (Pink Sheet)
  • Risk of More Dangerous Covid Strain Seen in South African Lab (Bloomberg)
  • UK To Use Vaccine Taskforce Model For ‘Cutting-Edge’ R&D Funding Program (Pink Sheet)
  • Switzerland experiencing medicine shortages says pharmacists association (Reuters)
  • Germany working to ensure continued cooperation between BioNTech, Chinese partner (Reuters)
  • WHO to phase out the name ‘monkeypox’ for ‘mpox’ (STAT) (Reuters) (Bloomberg) (NYT)
  • China eases Covid rules after wide protests of lockdowns (STAT)
  • Uganda's president extends Ebola epicentre's quarantine for 21 days (Reuters)
Pharma & Biotech
  • Spectrum Cuts NSCLC Program and 75% of Staff on Heels of CRL (Biospace) (Fierce) (Endpoints)
  • AbbVie links up with London VC firm to map out new anti-inflammatory companies (Fierce)
  • AstraZeneca beefs up COPD pipeline with $400M biobuck bet on C4X program (Fierce) (Reuters)
  • Racing rising resistance, Novartis marches malaria therapy into phase 3 (Fierce)
  • Axsome Headed to FDA after Phase III Alzheimer’s Agitation Win (Biospace)
  • US Partial Clinical Hold on Diamyd Phase III Trial Lifted by the FDA (Biospace)
  • Genentech starts phase 2 trial to optimize delivery of eye disease cell therapy (Fierce)
  • In new deal, AstraZeneca places small bet on 'critical but challenging' target (Endpoints)
  • Spying new horizons, Xeris starts work on subcutaneous version of rare disease drug (Fierce)
Medtech
  • It’s A Class I Recall For Baxter’s WatchCare Device (MedTech Dive) (MedTech Insight)
  • CAMD Says ‘Critical Appraisal’ Needed On EU MDR Capacity Bottlenecks (MedTech Insight)
  • Europe faces 2024 bottleneck in device reapprovals as submissions slow (MedTech Dive)
  • Payment Schemes For Innovative Medtech Exist In Just 8 European Countries – Report (MedTech Insight)
  • German Digital Health Strategy And EPR Project Get A Reboot (MedTech Insight)
  • Aidoc nets FDA clearances for AI detection of aortic tears, medium-vessel strokes (Fierce)
  • Philips respirator recall reaches 260 reported deaths, FDA says (MedTech Dive) (Fierce)
  • Everstone Said to Weigh Sale of $1 Billion Medical Device Firm (Bloomberg)
Government, Regulatory & Legal
  • Takeda, Generic Drug Makers Escape Class Antitrust Claims (Bloomberg)
  • Bayer Mostly Avoids Lawsuit Over Mirena IUD Cancer Risk, For Now (Bloomberg)
  • Drug Research Tech Patents Targeted in ITC Import Probe (Bloomberg)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

 

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